Upper respiratory disorders such as viral upper respiratory tract infections or “common cold”, allergic rhinitis, and rhinosinusitis are associated with impairment in mucociliary clearance in the nasal passages. Although the causes of these disorders are varied, they share a common set of nasal symptoms such as rhinorrhea, nasal congestion/blockage, and post-nasal drip. In these conditions the mucous membranes of the nose and paranasal sinuses become irritated, leading to symptoms. In some patients, this irritation is sufficient to hinder the normal drainage of the sinuses into the nasal cavity, resulting in blockage that may lead to additional impaired ciliary activity, intense pressure/pain, and increased likelihood of infection. Allergic rhinitis (AR) is a condition that results from exposure to allergens, either at specific times of the year (seasonal allergic rhinitis) or year-round (perennial allergic rhinitis). Up to one-half of AR patients suffer from both seasonal as well as perennial AR, approximately one-third suffer from seasonal AR alone and another one-third from perennial AR alone. In either seasonal or perennial AR, the symptoms and treatment approaches are similar. Symptoms most often include nasal congestion or stuffiness, rhinorrhea and nasal itching. Allergic rhinitis affects nearly 150 million people in the world's seven major pharmaceutical markets, and annual sales of prescription products to treat allergic rhinitis are estimated to total more than $4.5 billion worldwide. The treatments currently available include primarily prescription and over-the-counter antihistamines, decongestants and nasal corticosteroids, delivered by nasal sprays, evaporation devices, and ointments.
Upper Respiratory Tract Infections (URTI) and the common cold affect all ages and are uncomfortable conditions with lost work and school days.
Asthma and COPD (chronic obstructive pulmonary disease) are chronic illnesses requiring lifetime therapy and affect 44 million Americans. The mainstay of treatment is inhaler therapies. The delivery of medications via an inhaler is problematic causing decreased efficacy and poor patient compliance. Therefore there is a constant search for improving the delivery of drugs through inhalers.
The problem with current inhalers is the tendency of deposit of the medication in the oral cavity, not in the lungs where it is effective. Also, it is difficult to coordinate the delivery of the drug with the expiratory cycle. Because of these problems the accurate dosage of medication cannot be delivered and the treatment causes many side effects. In addition the current inhaler techniques are passive techniques that are based on the ability of the patient to suck the drug to the lungs. As their action on the patient is solely and totally drug-dependent, the above-mentioned faults cause a major problem to the user.
The pulsating inhaler delivery system works on the principal of successive small pulses of air (that can contain powder or liquid) in metered doses. This enhances delivery directly to lungs and increase efficacy. It does not require positioning or coordination with breathing. Therefore, there is minimal deposition in the oral cavity and minimal associated morbidity, e.g., dry mouth, bad taste, fungal infections. By delivering the medication with pulsation of small doses there will be an increase in bioavailability thus increasing the effectiveness of current inhalation medications. This method will be suitable for all medications, therefore very attractive to the patients. There will be an increase in patient compliance due to ease of use and increased feeling of effectiveness without the side effects that are currently a problem.
The pulsating inhaler will deliver drugs using unique device specific cartridges that will be disposable.
The efficient delivery of drugs to the lungs can also serve as a treatment modality for various systemic diseases such as the delivery of inhaled insulin to treat diabetes patients. These applications require accurate dosage that is difficult to achieve with the current inhaler technology.
The device has also non-drug dependent physiologic functions as it transfers vibration to the airways. Thus causing smooth muscle relaxation, reduction of airway edema, increase in blood and lymphatic flow, improved gas exchange and oxygenation and decreased dyspnea. As the device continue to oscillate during inspiration and expiration it provides a pulsating continuous positive airway pressure (PCPAP). The PCPAP prevents the collapse of the airways of the asthma and COPD patient, during expiration, which decreases dyspnea and is highly beneficial to the patients.